Prescription Drug Safety

Published on March 6, 2014

How are prescription drugs tested for safety?

1. The following information and statistics are derived from numerous medical journals,
including JAMA, The New England Journal of Medicine and Lancet.
• “Drug companies can conduct multiple studies on new drugs and then select and publish
the most favorable ones while suppressing the rest.”
• “Drug companies can choose research study designs that are more likely to reproduce
favorable results rather than designs that might provide more accurate results.”
• “Drug studies can measure a drug’s effectiveness in multiple ways, then select and
publish only the best results. Sometimes these favorable results have little to do with
whether drugs will help patients.”
• “Drug companies hire high-profile experts to place their names on drug companygenerated
articles, although the experts have not participated in the studies and their
financial connections with the drug companies are not disclosed.” 1
2. The FDA relies on the drug manufacturer’s research reports to approve a drug; no
independent testing is done or required.
3. USA Today found that 54% of the time, experts hired to advise the FDA on which medicine
should be approved for sale have a direct financial interest in the drug or topic they’re asked
to evaluate. 2
4. “It is simply not possible to identify all the adverse effects of drugs before they are
marketed,” say three medical doctors writing in the New England Journal of Medicine. 3
5. In fact, “Overall, 51% of approved drugs have serious side effects not detected prior to
approval. 4
1 Cohen, M.D., Jay, Overdose: The Case Against Drug Companies
2 Cauchon, Dennis, FDA Advisers Tied to Industry, USA Today, (25 Sept. 2002)
3 Wood, Alastair J.J. et al, Making Medicines Safer – The Need for an Independent Drug Safety Board, New
England Journal of Medicine, (17 Dec. 1998)
4 Moore, Thomas j. et al, Time to Act on Drug Safety, JAMA (20 May 1998)

How are the side effects of prescription drugs monitored?

1. There is no mandatory reporting of drug side effects for physicians or hospitals.
2. “Drug companies and medical institutions have their own reasons for underestimating
the full scope of the side-effect epidemic. Dr. David Bates, an associate professor of
medicine at the Harvard Medical School, wrote in JAMA.”
“Hospitals have had strong incentives not to identify too many of these adverse
drug events. Reporting large numbers of adverse events and any serious
preventable event brings intense scrutiny from regulators and the public. Thus,
most hospitals have relied on spontaneous reporting, which only identifies
about 1 in 20 adverse reactions and leads to the perception that injuries from
ADR’s are less common than they really are.” *
3. Monitoring Drug Safety – The FDA
The FDA monitors drug approval and safety. Here is how:
• The FDA has about 1300 employees processing new drug applications and
working toward drug approval: the review teams.
• The FDA has 72 employees tracking drug safety: the safety team.
• The FDA has a total budget of between $10 and $15 million per year. That is less
than Eli Lilly spent on its promotion of Prozac in 1997, according to The New
York Times. **
* Cohen, M.D., Jay, Overdose: The Case Against the Drug Companies.
** Pomper, Stephen, Drug Rush, Editor of The Washington Monthly..
WHAT ABOUT “DANGERIOUS AND UNPROVEN”
HERBAL REMEDIES?
Just how dangerous are herbal remedies?
• “According to the FDA, between 1993 and 1998 federal, state and local agencies
reported a total of 184 deaths, most of which were associated with weight loss
formulas.” 1
Compare these statistics to the following concerning prescription drugs:
• “According to the prestigious Journal of the American Medical Association and
New England Journal of Medicine, the side effects of properly prescribed drugs
are the 4th or 5th leading cause of death in the United States.”
• This doesn’t even include deaths from improperly prescribed drugs, deaths from
in-hospital errors and unreported drug deaths.”
• “If these were thrown into the statistics, drug treatment in general would easily be
in the top three causes of death in the nation.” 2
• In 1998, JAMA reported that more than 100,000 people die each year from
properly prescribed prescription drugs and each year 2,216,000 people require
hospitalization for life-threatening or permanently disabling side effects of
properly prescribed drugs.
• These stats are for hospitalized patients. No numbers exist for the larger group of
non-hospitalized patients.
• This amounts to over 300 deaths per day and 6,000 hospitalizations (only the most
serious side effects were tabulated in this study) from properly prescribed drugs.
• Add to this another 100,000 people who die annually from hospital-generated
infections. That is, infections contracted during a stay in a hospital, unrelated to
the original reason for being hospitalized. 3
• No other industry in this country would be allowed to continue doing business
with even a fraction of these mortality and morbidity statistics.
Note: More comprehensive medical mortality and morbidity statistics have been presented in
the widely circulated paper, “Death by Medicine,” written by Carolyn Dean, MD, ND, Gary
Null, PhD, Martin Feldman, MD, Debora Rasio, MD and Dorothy Smith, PhD in November,
2003. Dr. Carolyn Dean has recently published another book titled, “Death by Modern
Medicine.”
1 Goldberg, Burton, The Science of Deceit, in The John Lee Medical Letters, April (2002).
2 Lee, M.D., John, Sava, Ph.D., David & Hopkins, Virginia, What Your Doctor May Not Tell You About Breast
Cancer: How Hormone Balance Can Help Save Your Life, Warner Books, (2002) p20.
3 See http://www.cnn.com/2002/HEALTH/07/22gupta.germs.hiv.otsc/index.html.

Must everything in healthcare be validated through research?

“If ‘experimentally proven’ is the single criterion for a ‘non-quack’ medical practice, then almost
all modern medicine is pure quackery. Less than one in five of all currently traditionally
accepted medical practices have been proven effective in well-controlled, replicated studies over
time.”
“The remaining 80 percent of everything that is commonly done to us by doctors and hospitals
has never been thoroughly and conclusively researched.” *
Our health is our responsibility. However… becoming a more informed consumer allows each
of us to make “more informed choices.” What we say, do and eat today will make a difference
in our health tomorrow. It is our choice!
* Pearsall, Ph.D., Paul, Miracle in Maui, Inner Ocean Publishing, (1991) p33.

Do you take prescription drugs regularly? Have you thought about all natural chiropractic care?